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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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AcQMap - 00857042007241

AcQMap ECG Input Cable
ACUTUS MEDICAL, INC.
800421
Not in Commercial Distribution

  • 00857042007241 ()
800421

  • Cardiac mapping system

AcQMap - 00857042007234

AcQMap ECG Output Cable
ACUTUS MEDICAL, INC.
800424
Not in Commercial Distribution

  • 00857042007234 ()
800424

  • Cardiac mapping system

AcQMap - 00857042007135

Ampere® Adapter Cable AcQMap® Ampere
ACUTUS MEDICAL, INC.
800431
Not in Commercial Distribution

  • 00857042007135 ()
800431

  • Cardiac mapping system

AcQMap - 00857042007128

AcQMap® Surface ECG Cable
ACUTUS MEDICAL, INC.
800407
Not in Commercial Distribution

  • 00857042007128 ()
800407

  • Cardiac mapping system

AcQMap - 00857042007111

AcQMap® Auxiliary Catheter Cable
ACUTUS MEDICAL, INC.
800109
Not in Commercial Distribution

  • 00857042007111 ()
800109

  • Cardiac mapping system

AcQMap - 00857042007104

AcQMap® Ablation Interface Unit Cable
ACUTUS MEDICAL, INC.
800112
Not in Commercial Distribution

  • 00857042007104 ()
800112

  • Cardiac mapping system

AcQMap - 00857042007098

AcQMap® Patient Interface Unit Cable
ACUTUS MEDICAL, INC.
800113
Not in Commercial Distribution

  • 00857042007098 ()
800113

  • Cardiac mapping system

AcQMap - 00857042007081

AcQMap® Patient Interface Unit
ACUTUS MEDICAL, INC.
800229
Not in Commercial Distribution

  • 00857042007081 ()
800229

  • Cardiac mapping system

AcQMap - 00857042007067

AcQMap® Ablation Interface Unit
ACUTUS MEDICAL, INC.
800244-001
Not in Commercial Distribution

  • 00857042007067 ()
800244-001

  • Cardiac mapping system

AcQMap - 00857042007043

AcQMap® Console
ACUTUS MEDICAL, INC.
800258
Not in Commercial Distribution

  • 00857042007043 ()
800258

  • Cardiac mapping system

AcQMap - 00857042007005

North America Power Cord
ACUTUS MEDICAL, INC.
800426
Not in Commercial Distribution

  • 00857042007005 ()
800426

  • Cardiac mapping system

AcQMap - 00857042007999

AcQMap System
ACUTUS MEDICAL, INC.
900000
Not in Commercial Distribution

  • 00857042007999 ()
900000

  • Cardiac mapping system

AcQMap - 00857042007920

AcQMap System Console 2.0
ACUTUS MEDICAL, INC.
900100
Not in Commercial Distribution

  • 00857042007920 ()
900100

  • Cardiac mapping system

AcQMap - 00857042007326

AcQMap Ablation Reference Cable
ACUTUS MEDICAL, INC.
800505
Not in Commercial Distribution

  • 00857042007326 ()
800505

  • Cardiac mapping system

AcQMap - 00857042007302

AcQMap Auxiliary Interface Box
ACUTUS MEDICAL, INC.
800422
Not in Commercial Distribution

  • 00857042007302 ()
800422

  • Cardiac mapping system

AcQMap - 00857042007074

Ampere® Adapter Cable AcQMap® Ablation Catheter
ACUTUS MEDICAL, INC.
800430
Not in Commercial Distribution

  • 00857042007074 ()
800430

  • Cardiac mapping system

AcQMap - 00857042007050

AcQMap® Workstation
ACUTUS MEDICAL, INC.
800254
Not in Commercial Distribution

  • 00857042007050 ()
800254

  • Cardiac mapping system

Cardiopulonary Corp. - 00854709006074

No Description
Philips North America LLC
Surveillance Monitoring System Software
In Commercial Distribution

  • 00854709006074 ()


  • Centralized patient monitor

Bernoulli - 00854709006029

No Description
Philips North America LLC
Bernoulli One Software
In Commercial Distribution

  • 00854709006029 ()


  • Centralized patient monitor

Varex Digital Imaging Software, Nexus DR - 00854344007658

Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging.
VAREX IMAGING CORPORATION
v4.9
In Commercial Distribution

  • 00854344007658 ()


  • Angiographic x-ray system application software

Embrace Neonatal MRI System - 00858755006309

The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
ASPECT IMAGING LTD
Embrace
In Commercial Distribution

  • 00858755006309 ()
70007000

  • Full-body MRI system, permanent magnet

SPY-Q™ or SPY-QCM™ - 00858701006018

No Description
Novadaq Technologies Inc
SQ3500
In Commercial Distribution

  • 00858701006018 ()


  • Angiographic x-ray system application software

Happy Health - 00850068747177

No Description
HAPPY HEALTH, INC.
Happy Ring HR1401GB
In Commercial Distribution

  • 00850068747177 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747160

No Description
HAPPY HEALTH, INC.
Happy Ring HR1301GB
In Commercial Distribution

  • 00850068747160 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747153

No Description
HAPPY HEALTH, INC.
Happy Ring HR1201GB
In Commercial Distribution

  • 00850068747153 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747146

No Description
HAPPY HEALTH, INC.
Happy Ring HR1101GB
In Commercial Distribution

  • 00850068747146 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747139

No Description
HAPPY HEALTH, INC.
Happy Ring HR1001GB
In Commercial Distribution

  • 00850068747139 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747122

No Description
HAPPY HEALTH, INC.
Happy Ring HR0901GB
In Commercial Distribution

  • 00850068747122 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747115

No Description
HAPPY HEALTH, INC.
Happy Ring HR0801GB
In Commercial Distribution

  • 00850068747115 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747108

No Description
HAPPY HEALTH, INC.
Happy Ring HR0701GB
In Commercial Distribution

  • 00850068747108 ()


  • Multiple vital physiological parameter monitoring system, home-use

Happy Health - 00850068747092

No Description
HAPPY HEALTH, INC.
Happy Ring HR0601GB
In Commercial Distribution

  • 00850068747092 ()


  • Multiple vital physiological parameter monitoring system, home-use

Sibel Spacelabs Trek Tablet - 00850064210262

No Description
Sibel Health Inc.
900-00043
In Commercial Distribution

  • 00850064210262 ()


  • Wearable multiple vital physiological parameter monitor

Sibel Spacelabs Trek Charger - 00850064210224

No Description
Sibel Health Inc.
900-00046
In Commercial Distribution

  • 00850064210224 ()


  • Wearable multiple vital physiological parameter monitor

Central Hub Speaker - 00850064210194

Central Hub Speaker
Sibel Health Inc.
900-00004
In Commercial Distribution

  • 00850064210194 ()


  • Wearable multiple vital physiological parameter monitor

Central Hub CMS - 00850064210163

Central Hub CMS
Sibel Health Inc.
900-00013
In Commercial Distribution

  • 00850064210163 ()


  • Wearable multiple vital physiological parameter monitor

ANNE View Patient Monitor - 00850064210132

Patient monitor consisting of a mobile tablet and the ANNE View software. The ANNE View Patient Monitor connects to the ANNE Chest sensor, ANNE Limb sensor, and compatible devices for the real-time display of physiological data.
Sibel Health Inc.
900-00012
In Commercial Distribution

  • 00850064210132 ()


  • Wearable multiple vital physiological parameter monitor

7-Day ANNE Chest Adhesive Shelf Box - 00850064210101

Box of 30 7-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00010
In Commercial Distribution

  • 00850064210101 ()


  • Wearable multiple vital physiological parameter monitor

ANNE Bedside Wireless Charger - 00850064210057

Bedside charger for the ANNE Chest and ANNE Limb sensors.
Sibel Health Inc.
900-00008
In Commercial Distribution

  • 00850064210057 ()


  • Wearable multiple vital physiological parameter monitor

1-Day ANNE Chest Adhesive Pouch - 00850064210026

Pouch of 10 1-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00014
In Commercial Distribution

  • 00850064210026 ()


  • Wearable multiple vital physiological parameter monitor

7-Day ANNE Chest Adhesive Pouch - 00850064210019

Pouch of 5 7-Day Adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00038
In Commercial Distribution

  • 00850064210019 ()


  • Wearable multiple vital physiological parameter monitor
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